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Targeting mTOR with everolimus and/or physical training for preventing postmenopausal bone loss and accelerated skeletal aging. The RapaLoad study.
EU CTIS ID: 2023-508093-28-00
What this study is testing
This study aims to determine if treatment with everolimus, exercise training, or their combination for 24 weeks enhances bone formation in healthy postmenopausal women.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Postmenopausal women aged 45-60 years old as evidenced by measuring serum levels of LH and FSH and absence of menstruation for at least 1 year.
- - No history of low energy hip or vertebral fractures during the last 6 months.
- Ability to provide informed consent.
You likely can't join if
- - Diabetes (type 1 and 2)
- Patients with impaired wound healing or history of a chronic open wound
- Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemother-apy or any other treatment for malignancy
- Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history of dyslipidemia, Total cho-lesterol > 9.1 mmol/L, or triglycerides > 9.9 mmol/L
- Any form of clinically relevant primary or secondary immune dysfunction or deficiency
- Unstable ischemic heart disease
See the full eligibility criteria
- - Postmenopausal women aged 45-60 years old as evidenced by measuring serum levels of LH and FSH and absence of menstruation for at least 1 year.
- - No history of low energy hip or vertebral fractures during the last 6 months.
- Ability to provide informed consent.
- - Diabetes (type 1 and 2)
- Patients with impaired wound healing or history of a chronic open wound
- Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemother-apy or any other treatment for malignancy
- Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history of dyslipidemia, Total cho-lesterol > 9.1 mmol/L, or triglycerides > 9.9 mmol/L
- Any form of clinically relevant primary or secondary immune dysfunction or deficiency
- Unstable ischemic heart disease
- Bone mineral density (BMD) measured by DXA scanning with T-score <-3
- Known allergy to rapamycin or rapalogs
- The study will exclude participants with inability to speak and understand Danish and with ina-bility to cooperate or perform physical training
- Inability to give informed consent
- Heart failure similar to NYHA Class IV
- Primary hyperparathyroidism
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal im-pairment (eGFR <20) or liver function (baseline phosphatase higher than twice upper limit (105 U/L)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing’s disease
- Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years
- Use of anabolic steroids in the previous year
- Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metab-olism
- History of coagulopathy or medical condition requiring long-term anticoagulation
- Anemia – Hg < 9.0 g/dl, Leukopenia – white blood cells (WBC) < 3,500/mm3, Neutropenia abso-lute neutrophil count < 2,000/mm3, or Platelet count – platelet count < 125,000/mm3
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.